Vybhav Jetty, Charles J Glueck, Ping Wang, Parth Shah, Marloe Prince, Kevin Lee, Michael Goldenberg, Ashwin Kumar
{"title":"50,000-100,000单位维生素D3/周治疗维生素d缺乏、高胆固醇血症伴可逆性他汀类药物不耐受患者的安全性","authors":"Vybhav Jetty, Charles J Glueck, Ping Wang, Parth Shah, Marloe Prince, Kevin Lee, Michael Goldenberg, Ashwin Kumar","doi":"10.4103/1947-2714.179133","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Vitamin D deficiency (<32 ng/mL) is a reversible cause of statin-intolerance, usually requiring vitamin D3 (50,000-100,000 IU/week) to normalize serum D, allowing reinstitution of statins. Longitudinal safety assessment of serum vitamin D, calcium, and estimated glomerular filtration rate (eGFR) is important.</p><p><strong>Aims: </strong>Prospectively assess the safety-efficacy of vitamin D3 therapy.</p><p><strong>Materials and methods: </strong>In 282 statin-intolerant hypercholesterolemic patients for 6 months and in 112 of the 282 patients for 12 months, with low-entry serum vitamin D (<32 ng/mL), we assessed safety-efficacy of vitamin D3 therapy (50,000-100,000 IU/week).</p><p><strong>Results: </strong>On mean (66,600 IU) and median (50,000 IU) of vitamin D3/week in 282 patients at 6 months, serum vitamin D rose from pretreatment (21-median) to 46 ng/mL (P < 0.0001), and became high (>100 ng/mL) but not toxic (>150 ng/mL) in 4 patients (1.4%). Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 at 6 months (P = .36), with no trend of change (P = .16). Median eGFR was unchanged from entry (84 mL/min/1.73) to 83 at 6 months (P = .57), with no trend of change (P = .59). On vitamin D3 71,700 (mean) and 50,000 IU/week (median) at 12 months in 112 patients, serum vitamin D rose from pretreatment (21-median) to 51 ng/mL (P < 0.0001), and became high (>100 but <150 ng/mL) in 1 (0.9%) at 12 months. Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 mg/dL and 9.60 mg/dL at 6 months and 12 months, respectively; P > 0.3. eGFR did not change from 79 mL/min/1.73 at entry to 74 mL/min/1.73 and 77 mL/min/1.73 at 6 months and 12 months, P > 0.3. There was no trend in the change in serum calcium (P > 0.5 for 6 months and 12 months), and no change of eGFR for 6 months and 12 months, P > 0.15.</p><p><strong>Conclusions: </strong>Vitamin D3 therapy (50,000-100,000 IU/week) was safe and effective when given for 12 months to reverse statin intolerance in patients with vitamin D deficiency. Serum vitamin D rarely exceeded 100 ng/mL, never reached toxic levels, and there were no significant change in serum calcium or eGFR.</p>","PeriodicalId":19703,"journal":{"name":"North American Journal of Medical Sciences","volume":"8 3","pages":"156-62"},"PeriodicalIF":0.0000,"publicationDate":"2016-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9e/a0/NAJMS-8-156.PMC4821095.pdf","citationCount":"22","resultStr":"{\"title\":\"Safety of 50,000-100,000 Units of Vitamin D3/Week in Vitamin D-Deficient, Hypercholesterolemic Patients with Reversible Statin Intolerance.\",\"authors\":\"Vybhav Jetty, Charles J Glueck, Ping Wang, Parth Shah, Marloe Prince, Kevin Lee, Michael Goldenberg, Ashwin Kumar\",\"doi\":\"10.4103/1947-2714.179133\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Vitamin D deficiency (<32 ng/mL) is a reversible cause of statin-intolerance, usually requiring vitamin D3 (50,000-100,000 IU/week) to normalize serum D, allowing reinstitution of statins. Longitudinal safety assessment of serum vitamin D, calcium, and estimated glomerular filtration rate (eGFR) is important.</p><p><strong>Aims: </strong>Prospectively assess the safety-efficacy of vitamin D3 therapy.</p><p><strong>Materials and methods: </strong>In 282 statin-intolerant hypercholesterolemic patients for 6 months and in 112 of the 282 patients for 12 months, with low-entry serum vitamin D (<32 ng/mL), we assessed safety-efficacy of vitamin D3 therapy (50,000-100,000 IU/week).</p><p><strong>Results: </strong>On mean (66,600 IU) and median (50,000 IU) of vitamin D3/week in 282 patients at 6 months, serum vitamin D rose from pretreatment (21-median) to 46 ng/mL (P < 0.0001), and became high (>100 ng/mL) but not toxic (>150 ng/mL) in 4 patients (1.4%). Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 at 6 months (P = .36), with no trend of change (P = .16). Median eGFR was unchanged from entry (84 mL/min/1.73) to 83 at 6 months (P = .57), with no trend of change (P = .59). On vitamin D3 71,700 (mean) and 50,000 IU/week (median) at 12 months in 112 patients, serum vitamin D rose from pretreatment (21-median) to 51 ng/mL (P < 0.0001), and became high (>100 but <150 ng/mL) in 1 (0.9%) at 12 months. Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 mg/dL and 9.60 mg/dL at 6 months and 12 months, respectively; P > 0.3. eGFR did not change from 79 mL/min/1.73 at entry to 74 mL/min/1.73 and 77 mL/min/1.73 at 6 months and 12 months, P > 0.3. There was no trend in the change in serum calcium (P > 0.5 for 6 months and 12 months), and no change of eGFR for 6 months and 12 months, P > 0.15.</p><p><strong>Conclusions: </strong>Vitamin D3 therapy (50,000-100,000 IU/week) was safe and effective when given for 12 months to reverse statin intolerance in patients with vitamin D deficiency. Serum vitamin D rarely exceeded 100 ng/mL, never reached toxic levels, and there were no significant change in serum calcium or eGFR.</p>\",\"PeriodicalId\":19703,\"journal\":{\"name\":\"North American Journal of Medical Sciences\",\"volume\":\"8 3\",\"pages\":\"156-62\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2016-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9e/a0/NAJMS-8-156.PMC4821095.pdf\",\"citationCount\":\"22\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"North American Journal of Medical Sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/1947-2714.179133\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"North American Journal of Medical Sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/1947-2714.179133","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Safety of 50,000-100,000 Units of Vitamin D3/Week in Vitamin D-Deficient, Hypercholesterolemic Patients with Reversible Statin Intolerance.
Background: Vitamin D deficiency (<32 ng/mL) is a reversible cause of statin-intolerance, usually requiring vitamin D3 (50,000-100,000 IU/week) to normalize serum D, allowing reinstitution of statins. Longitudinal safety assessment of serum vitamin D, calcium, and estimated glomerular filtration rate (eGFR) is important.
Aims: Prospectively assess the safety-efficacy of vitamin D3 therapy.
Materials and methods: In 282 statin-intolerant hypercholesterolemic patients for 6 months and in 112 of the 282 patients for 12 months, with low-entry serum vitamin D (<32 ng/mL), we assessed safety-efficacy of vitamin D3 therapy (50,000-100,000 IU/week).
Results: On mean (66,600 IU) and median (50,000 IU) of vitamin D3/week in 282 patients at 6 months, serum vitamin D rose from pretreatment (21-median) to 46 ng/mL (P < 0.0001), and became high (>100 ng/mL) but not toxic (>150 ng/mL) in 4 patients (1.4%). Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 at 6 months (P = .36), with no trend of change (P = .16). Median eGFR was unchanged from entry (84 mL/min/1.73) to 83 at 6 months (P = .57), with no trend of change (P = .59). On vitamin D3 71,700 (mean) and 50,000 IU/week (median) at 12 months in 112 patients, serum vitamin D rose from pretreatment (21-median) to 51 ng/mL (P < 0.0001), and became high (>100 but <150 ng/mL) in 1 (0.9%) at 12 months. Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 mg/dL and 9.60 mg/dL at 6 months and 12 months, respectively; P > 0.3. eGFR did not change from 79 mL/min/1.73 at entry to 74 mL/min/1.73 and 77 mL/min/1.73 at 6 months and 12 months, P > 0.3. There was no trend in the change in serum calcium (P > 0.5 for 6 months and 12 months), and no change of eGFR for 6 months and 12 months, P > 0.15.
Conclusions: Vitamin D3 therapy (50,000-100,000 IU/week) was safe and effective when given for 12 months to reverse statin intolerance in patients with vitamin D deficiency. Serum vitamin D rarely exceeded 100 ng/mL, never reached toxic levels, and there were no significant change in serum calcium or eGFR.